Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy

Part of paid clinical trials in Lakewood Rch, Florida.

Sponsor
Zydus Therapeutics Inc.
Study ID
NCT07424677
Phase
PHASE3
Status
Recruiting
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Conditions

  • Primary Biliary Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Saroglitazar Magnesium 1 mg — DRUG
    Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast
  • Placebo — DRUG
    Matching Placebo once daily, orally each morning before breakfast

Study Details

Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy

Key Dates

First listed
Feb 20, 2026
Start date
Aug 11, 2026
Status verified
Sep 2026
Primary completion
Jul 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Saroglitazar Magnesium 1 mg
    Saroglitazar magnesium 1 mg, once daily, orally each morning before breakfast
  • Placebo Comparator: Placebo
    Matching Placebo once daily, orally each morning before breakfast

Primary Outcome Measure

The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP [ Time Frame: Baseline to Week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
US203Lakewood RchFlorida34211
Myrlande Elichne
[email protected]

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US203· Lakewood Rch, FL

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